Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

Pfizer

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: CP-690,550; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00147498

A3921019

Details and patient eligibility

About

The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).

Enrollment: 264 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)

Exclusion criteria

• Current Therapy With Any DMARD Or Biologic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 4 patient groups, including a placebo group

5 mg BID

Experimental group

Description:

CP 690,550 5 mg BID

Treatment:

Drug: CP-690,550

15 mg BID

Experimental group

Description:

CP 690,550 15 mg BID

Treatment:

Drug: CP-690,550

30 mg BID

Experimental group

Description:

Oral tablets administered at a dose of 30 mg BID for 6 weeks

Treatment:

Drug: CP-690,550

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo